There are numerous problems associated with clinical trials. One problem relates to patient compliance issues. As part of a trial, patients may be required to self-report data. The type of data may vary considerably dependent upon the particular protocols of the clinical trial. Examples of such data may include when medication were taken, whether exercises were performed, level of pain being experienced, etc. However, even conscientious participant in a clinical trial may find it difficult to comply with reporting requirements. Patient compliance issues are significant because these issues can potentially affect the validity or results of a clinical trial or study. Thus, patient compliance problems may potentially change the outcome of a clinical trial study, such as causing a safe and effective pharmaceutical or treatment to fail to receive approval, or to create gaps in the understanding of a particular pharmaceutical or treatment.
Various attempts have been made at addressing these problems. One example of such an approach is for a participant to use a diary or electronic diary to record self-reporting information. Yet, there are still problems with such an approach. Clinical trial participants may find it difficult or inconvenient to record information whether in a diary or electronic diary or may forget to record the information periodically, or may attempt to reconstruct the information too long after the fact to be accurate.
In addition to these issues with diaries and electronic diaries, such systems are limited in functionality. What is needed are systems and methods which integrate self-reports of participants in clinical studies with other medical information associated with the patient and which allow the patient to selectively disseminate that information, including to clinical trial sponsors.